OWF · Class I · 21 CFR 866.3110

FDA Product Code OWF: Immunohistochemical Assay, Helicobacter Pylori

Anti-helicobacter Pylori Rabbit Monoclonal Primary Antibody Is Designed To Qualitatively Detect The Presence Of Helicobacter Pylori In Formalin-fixed, Paraffin-embedded Gastric Biopsy Tissue Via Light Microscopy. Immunohistochemical Staining With This Antibody Product May Aid In The Diagnosis Of Helicobacter Pylori Infection. This Product Should Be Interpreted By A Qualified Pathologist In Conjunction With Histological Examination, Relevant Clinical Information And Proper Controls. This Antibody Is Intended For In Vitro Diagnostic (ivd) Use

1
Total
1
Cleared
479d
Avg days
2011
Since

FDA 510(k) Cleared Immunohistochemical Assay, Helicobacter Pylori Devices (Product Code OWF)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OWF - Regulatory Context